BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 108775 · Received July 8, 1997

    Report

    Report Number
    2124215-1997-01656
    Event Type
    Malfunction
    Date Received
    July 8, 1997
    Date of Event
    April 4, 1997
    Report Date
    April 4, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS VENTAK PRX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND IN MONITOR ONLY MODE (THERAPY DELIVERY DISABLED). THE PATIENT REPORTED THAT HE HAD BEEN EXPOSED TO A MAGNET IN HIS STEREO SYSTEM. NOTE: THE VENTAK PRX PHYSICIAN'S MANUAL (CPI PUBLICATION 352927) PAGE 74 STATES: '...PATIENTS SHOULD AVOID EQUIPMENT OR SITUATIONS WHERE THEIR DEVICE WOULD BE EXPOSED TO STRONG (>10 GAUSS) MAGNETIC FIELDS.' THIS ICD FALLS UNDER FDA SAFETY ALERT FDA # N030/031-5. THE PHYSICIAN WAS NOTIFIED ON 4/18/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1705 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other THE DEVICE 0074/200046 WAS IMPLANTED 28-JAN-1994| THE DEVICE 6836/007847 WAS IMPLANTED 28-JAN-1994| THE DEVICE 0063/004572 WAS IMPLANTED 28-JAN-1994